Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

NCT ID: NCT04170127

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-02

Study Completion Date

2019-08-02

Brief Summary

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The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.

Detailed Description

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Conditions

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Malocclusion, Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Right side of the maxilla

the right side of the maxilla

Group Type EXPERIMENTAL

Irradiation of implants with 635nm laser

Intervention Type PROCEDURE

Irradiation of implants with 635nm laser

Left side of the maxilla

left side of the maxilla

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Irradiation of implants with 635nm laser

Irradiation of implants with 635nm laser

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
* the patients were treated first time using fixed orthodontic appliance;
* no systemic diseases;
* were not using anti-inflammatory drugs;

Exclusion Criteria

* had used antibiotics in the previous 24 months;
* smokers;
* had history of radiotherapy,
* taking bisphosphonate medication
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jacek Matys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Private Dental Healtcare

Wschowa, , Poland

Site Status

Countries

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Poland

Other Identifiers

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WroclawMU6354J

Identifier Type: -

Identifier Source: org_study_id

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